a study to evaluate the safety and efficacy of cr845 in chronic kidney disease patients with moderate-to-severe pruritus

Conditions: Chronic Kidney Diseases; Pruritus

Summary: this is a multicenter, double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of 3 dose levels of oral cr845 compared to placebo in reducing the intensity of itch in chronic kidney disease (ckd) patients with moderate-to-severe pruritus. this study will consist of a screening period, a 7-day run-in period, a 12 week treatment period, and a follow-up visit (approximately 7 days after the last dose of study drug).

this study will consist of a screening period, a 7-day run-in period, a 12 week treatment period, and a follow-up visit (approximately 7 to 10 days after the last dose of study drug). informed consent will be obtained prior to performing any study-specific procedures. screening will occur within 7 to 28 days prior to randomization to assess eligibility. if patients continue to meet all inclusion and no exclusion criteria at the end of the 7-day run-in period, they will be randomized in a 1:1:1:1 ratio to receive orally once daily either placebo or cr845 tablets at doses of 0.25, 0.5 or 1 mg. randomization will be stratified according to the patient's renal disease status: moderate ckd; severe ckd non-dialysis; severe ckd on dialysis (ie, 3 categories). a final safety follow-up visit will be conducted 7 to 10 days after the last dose of study drug.

Eligibility criteria:
inclusion criteria: to be eligible for inclusion into the study, a patient must meet the following criteria: * ckd patients with stage iii, iv, or v (ie, moderate renal impairment with estimated glomerular filtration rate (gfr) ≥30 and \<60 ml/min/1.73 m2 or severe renal impairment with estimated gfr \<30 ml/min/1.73 m2). * for severe ckd patients on hemodialysis, they must be receiving hemodialysis 3 times per week for at least 3 months prior to the start of screening; * prior to randomization: 1. has completed at least 4 worst itching intensity nrs worksheets from the start of the 7-day run-in period; 2. has a mean baseline worst itching intensity nrs score ≥5, defined as the average of all non-missing scores reported from the start of the 7-day run-in period. exclusion criteria: a patient will be excluded from the study if any of the following criteria are met: * patients not currently on dialysis who are likely to initiate routine dialysis during study participation; * scheduled to receive a kidney transplant during the study; * new or change of treatment received for itch including antihistamines and corticosteroids (oral, intravenous \[iv\], or topical) within 14 days prior to screening; * received another investigational drug within 30 days prior to the start of screening or is planning to participate in another clinical study while enrolled in this study; * received ultraviolet b treatment within 30 days prior to the start of screening or anticipates receiving such treatment during the study; * participated in a previous clinical study with cr845.

Keywords: difelikefalin cr845 pruritus chronic itch itch itching uremic pruritus ckd ckd-ap ckd-associated pruritus chronic kidney disease kidney dysfunction generalized pruritus hemodialysis dialysis esrd (end stage renal disease) kidney failure, chronic